PROJECT SUMMARY/ABSTRACT The Molecular Pharmacology Shared Resource (MPSR) provides a mechanism for high-quality collection, processing and analysis of clinical specimens for pharmacokinetic and correlative studies from clinical trial patients. Additionally, this resource conducts preclinical modeling of novel anticancer agents and therapeutic combinations to explore promising avenues for clinical trial design. The resource participates in all levels of our clinical trials program, from preclinical study rationale, protocol development, novel assay development, specimen collection, correlative analysis of patient material, data analysis and publication. The MPSR offers the following categories of services for our investigators: 1) Specimen Collection: The MPSR oversees blood and other surrogate cell collection for patients enrolled on clinical trials conducted at UCDCCC. This service is utilized by clinical investigators executing clinical trials that include a specimen collection component. Virtually all research blood collection conducted at our Cancer Center on clinical trials patients is overseen by the MPSR, regardless of its complexity. The MPSR has substantial specialized specimen collection and processing capabilities, particularly for pharmacokinetic and pharmacodynamic analysis. This HIPAA-compliant resource meets or exceeds all University, local, state and federal regulations necessary for these services. 2) Correlative Studies: The MPSR is particularly vested in the identification and validation of biomarkers and molecular signatures predictive of patient outcome. In addition to CLIA-certified biomarker testing conducted jointly with the UC Davis Molecular Diagnostics Laboratories utilized in Phase II and III studies, we focus on investigational/developmental assays typically performed in conjunction with our early phase clinical trial program. The MPSR conducts analysis and research at our labs on the Sacramento campus or partners with outside labs or commercial entities. In either scenario, the MPSR is responsible for specimen shipping, tracking and anonymization, and is the recipient of the data generated. 3) Preclinical Modeling: The Shared Resource also conducts preclinical modeling and translational research with clinical impact, and works with UCDCCC investigators to establish and test strategies in the laboratory for personalized medicine that are translatable to the clinic. In addition to a variety of cell line- and traditional xenograft-based analyses, the MPSR functions as a link between clinical investigators at UCD and our colleagues at The Jackson Laboratory (JAX) for studies involving patient-derived xenografts (PDXs). The MPSR is by far the biggest user at UCDCCC of the JAX PDX modeling system and has played an integral role in the development of this resource.